65757-654 : Lybalvi Oral Tablet, Film Coated


NDC65757-654
Labeler: Alkermes, Inc.
Product Type: Human Prescription Drug
Drug Name:  Lybalvi
Dosage Form: Oral Tablet, Film Coated
Application #: NDA213378
Rev. Date: 


NDC Package Codes:

  • 65757-654-40: 1 BOTTLE IN 1 CARTON (65757‑654‑40) > 7 TABLET, FILM COATED IN 1 BOTTLE
  • 65757-654-41: 1 BOTTLE IN 1 CARTON (65757‑654‑41) > 7 TABLET, FILM COATED IN 1 BOTTLE
  • 65757-654-42: 1 BOTTLE IN 1 CARTON (65757‑654‑42) > 30 TABLET, FILM COATED IN 1 BOTTLE
  • 65757-654-44: 1 BOTTLE IN 1 CARTON (65757‑654‑44) > 90 TABLET, FILM COATED IN 1 BOTTLE

Active Ingredients:

  • Olanzapine
  • Samidorphan L-malate

Dosage Strength:

  • 20 mg
  • 10 mg

Pharmaceutical Classes:

  • Atypical Antipsychotic [EPC]

Related Products:

Based on records with the same trade name.
  • 65757-651 Lybalvi Oral Tablet, Film Coated by Alkermes, Inc.
  • 65757-652 Lybalvi Oral Tablet, Film Coated by Alkermes, Inc.
  • 65757-653 Lybalvi Oral Tablet, Film Coated by Alkermes, Inc.

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Note: The RxChat NDC Database uses publicly available data from the FDA and the U.S. National Library of Medicine (NLM); The NLM is not responsible for the data presented and does not endorse or recommend this or any other product. While we make every effort to ensure that the information presented is accurate, you should assume that all results are unvalidated. To report any errors or inconsistencies please contact us.